MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL 3RD EDITION 660IMS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72200242S3E
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 600ims had a burning smell.No patient injury was reported.
Additional Manufacturer Narrative
There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of product and no damage was observed.Complaint of burning was confirmed.Unit did power up and pass functional testing but a burnt odor was detected.A capacitor on the voltage regulator pcb was found burnt.Reason for burnt capacitor could be sudden power surge to power supply.The complaint investigation has concluded the cause of the failure to be a defective electronic component.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

• Brand Name: SVCE REPL 3RD EDITION 660IMS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7026732
• Report Number: 1643264-2017-01721
• Device Sequence Number: 16421365
• Product Code: GCJ
• UDI-Device Identifier: 00885554030846
• UDI-Public: (01)00885554030846
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K060777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72200242S3E
• Device Catalogue Number: 72200242S3E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1